Yes, I think we'll start. So good morning, everyone, and thank you for joining this session of the Morgan Stanley Global Healthcare Conference. I am Thibault Boutin. I am part of the European Pharma Equity Research team based in London. Before we start, I need to refer to some important disclosures. Please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. So for this session, I am delighted to have with me Richard Saynor, CEO of Sandoz, Remco Steenbergen, CFO, and Keren Haruvi, Head of North America. So thank you very much for joining us today.
So we'll start, you know, with, we'll do a Q&A very quickly, but before we start, maybe Richard, would you like to start with some introductory comments and maybe come back on some of the key takeaways from your recent strategic update?
Yeah, thank you. First of all, thank you so much for the invite, and it's a pleasure to be here. Look, it's pretty much a year to the day that we were last in New York and London with our first capital markets day. I guess since then, clearly we've spun the company. We've got delivered strong momentum. I think now 12 straight quarters of growth, delivered 7% growth in our first half, but actually, the thing I'm most proud of is really the filings and approvals that we committed to this time last year. Pretty much now, every one of those products, we've now filed many of those products, now we've launched, and start really now moving the momentum, particularly the biologics business.
I know there'll be questions about the US evolution, but particularly proud how Keren and the team have done a phenomenal job turning the US business around and delivering growth, particularly in biosimilars. Ultimately, we operate in a very attractive market. Today, it's about $200 billion, with nearly $400 billion of LOE looking towards us. There's something called GLP-1s, that they may not be coming off, so-
Other things
No doubt we'll talk about those a little bit today. But also a significant number of biosimilars, and I think we've positioned ourselves now as the world's leading biosimilar company, which is a strong foundation to go forward. So, a lot has happened in our first year, but, very pleased and very proud of what we've achieved.
Perfect. Thank you for the introductory comments, and let's jump straight into biosimilars. And, everyone is, I think, interested and excited about what's happening with biosimilar Humira in the US, in particular. So if you could give us an update on the progress you've made here, you know, maybe starting with, the, the sales from, your private label deal with, you know, Cordavis, the subsidiary of CVS. It has done incredibly well. So the question is, how much more room for growth there is here in terms of volume? Or has this channel already reached, some level of maturity already?
I think, Keren, that's a question for you.
Thank you. Yeah, so first of all, we are very pleased from our collaboration with Cordavis. You know, it was a unique opportunity to be the first company to bring private label into the United States and really to open access to patients. And, you know, we launched in July 2023, and we didn't see too much pickup, and definitely but by doing this, we saw access. Now in the market, there is 19% access for biosimilar, again, based on the public IQVIA data, and 80% of this 19% is held by Sandoz. So we are very proud from what we achieved, both in the private label and not in the private label.
To your question on our ability to grow the volume, I would say from a pure CVS perspective, we probably achieved more or less steady state in the specific segment, the commercial segment, where we're playing. Definitely, there are other opportunities with CVS, and there are other books of business, but also we see an opportunity with other payers. So again, as you know, CVS is the only payer so far to displace Humira. ESI announced with Cigna that they will displace Humira in some of their plans in 2025. Optum announced yesterday that they will do the same. Again, in Cigna, we are gonna be in their formulary, so we'll continue to drive growth there, and we're looking at other opportunities. So I would not say that we got to where we want to as an industry.
You know, 19% is not enough, but definitely there is still room for growth.
Perfect. And zooming in a bit on this private label deal, I think one of the key questions we have is, you know, what is the agreement with Cordavis? You know, I think you said it's a multi-year, so if you could come back on the stability we can expect from this channel, and also if you could maybe tell us if you have a sort of, you know, first right to renew option on this contract or some sort of tools to renegotiate down the line and be maybe first in line to kind of continue this contract.
Yeah. So first of all, we did share that the agreement with Cordavis is a multi-year agreement, so it was not just a one-year agreement. I would say that both Cordavis and us are very happy with the outcome. You know, Cordavis kind of announced that they had more than 90%, you know, conversion, so definitely it was success. I would say we both committed to patients. At the end of the day, you know, it's a chronic disease. Patients are getting used to the device, et cetera. So there is an aim from both companies to continue and then support patients in a most kind of consistent way.
Okay. That's, that's very helpful. And then just talking maybe a little bit about ex-US for biosimilar Humira. Yeah, how sustainable the growth is here, because you've done very, very well. I think you're clearly one of the leader, if not the leader, on biosimilar Humira ex-US. So how should we think about that and how much more room for growth there is here as well?
I guess, look, I mean, look, Europe was growing mid-teens for the last three, four years and continues to do so. You've got to remember that a lot of patients, we just weren't able to access biologics because of the price points. And as, I think even in Germany, it was about five years from diagnosis to treatment for rheumatoid arthritis, so that time is coming down. So clearly, the patient pool is expanding. And also, we're now bringing these products more and more to the other of the international markets as well. So it's not static. It's not like everything launches at the same time, and you get complete conversion. So you see steady momentum, and I guess the best example of that is Omnitrope. I mean, we launched Omnitrope eighteen years ago, and it's still growing.
Today, we're the world's largest supplier of human growth hormone. It's a business that's, you know, very attractive, continues to grow. And, you know, I think it still has potential to continue. I think it plays to the bank, really, the main difference between a lot of the biologics and simple molecules. When you look further forward, a drug like Denosumab, huge potential for growth, given the indication for osteoporosis and then how you access those patients, and then they're frequently on these drugs for very long periods of time. I think there's a lot of room to grow.
Absolutely. So continued growth ex U.S., and going back to the U.S. with a similar question, but I guess the question is, on U.S. biosimilar, I think what we've seen in the past for some other biosimilars is a sort of time to peak of maybe calling it two to four years. And then we started to see a decline as the price erosion were kind of more than the volume growth. So for Humira in particular, you mentioned the room you have to grow is in some other channel outside of Cordavis and CVS.
So how should you think about the shape of U.S. biosimilar Humira, and could it be consistently growing, or should we also expect the sort of bell curve in terms of reaching peak sales and then expecting an erosion?
Yeah, first of all, I would say the two to four years is probably more kind of medical benefit product. That's what we saw, and you are correct that once you kind of get to your share, we start to see the ASP kind of erosion, right? And then this balance between volume and value that you need to kind of manage consistently. So I would say in the medical benefit, definitely we see two to four years to peak, and we do see a great penetration, 80%, I would say, share for biosimilars, if you look at most of their launch in this space. In the pharmacy benefit, it's different. Again, this is the first, honestly, a pharmacy benefit, you know, launch in biosimilars.
I would be careful in saying exactly how it would behave, but, as I shared before, we do believe that probably it will be, we achieve probably the share that we anticipate in the CVS book of business, and then we'll see how the others will behave. There are also other kind of, you know, factors, including what PBMs will do with other brands in the category, et cetera. So it's not just about the conversion, it's also how the overall market will behave on the other market.
And also don't forget there's opportunities to gain. You know, most insurers have treatment protocols, how those protocols evolve, because the ultimate, over time, the cost of these drugs comes down and then become more accessible. So there's, again, the potential pool of patients who aren't receiving products, that could be receiving products over the medium term.
Very clear. And just maybe focusing a little bit on the specific opportunity within the U.S. market is recently, as you mentioned, Express Scripts announced that they would remove branded Humira from their label starting in January 2025. They have their own private label deal, at least kind of Cigna, which is the, you know, the parent organization has a private label deal with Teva, Alvotech and Boehringer. But biosimilar of Sandoz is still on the preferred formulary. So how should you think about - How should we think about this, and how much upside do you see in that formulary exclusion opportunity, where Cigna is basically removing brand Humira?
Yeah, I think it's early days. We definitely think there is a significant opportunity for us, and we are very pleased that we remain on formulary. I would say you need to think about it at the end of the day, and the chain and the control that the PBM have, has overall, and I do think that there are a lot of other specialty pharmacies kind of working with Cigna beyond Accredo. So we do think there is a significant opportunity for us still to achieve share. And I think the fact that we were early to the market, early with our private label, we do have advantage. We do have already many patients on this product, and I don't think that, you know, they will move now to the private label.
The part of being first really help us to make sure we have those patients.
That's clear. Switching to biosimilar Stelara, so you have visibility on the launch date in the US next year. Are you in discussion already for a similar private label deal, you know, similar to what you did with Humira? And could there also potentially be a provider for multiple PBMs rather than having, you know, sort of kind of exclusion deal with exclusive deal, sorry, with a specific PBM on Stelara or even other biosimilars in the future?
You want me?
Go for it.
Yeah, yeah. No, no.
You get all the difficult questions now.
Yeah, I know. So first of all, we're very pleased that we have now also biosimilar to Stelara, you know, ustekinumab, as you mentioned in our portfolio. It's a new addition, and we'll be able to launch in the first wave, you know, with other companies in Q1 2025. If we anticipate the market to go in a similar direction, I would say probably yes. We just saw also yesterday, again, Optum announced that they will do it for their private label with Secukinumab. We are not sharing yet what will be our commercial approach. We believe it's too early to share, but but definitely we will see similar kind of dynamics in the market.
Okay, very well. That's clear. Moving a little bit on the U.S. generics, I think the sales declined a little bit in H1. Can you comment on the price dynamics in this market? You know, how your pipeline can help compensate for this in the future? And some color on, you mentioned generic launches that you would expect to launch in the U.S. in the second half of the year. So a bit more, maybe kind of like to hear, if you can.
Yeah. So I'll start from the price erosion perspective. You know, we're not sharing it by region, but we did share, you know, the overall, the global kind of price erosion, and it's pretty consistent to what we've seen in the past. So I don't anticipate to see specifically this year, more price erosion. And I always like to say that, you know, markets are not eroding, it's the specific products. And if you look at our portfolio in generics, it's very mature. I also always say that prices in the generic space are, to some extent, too low. So I don't think there is a lot of room in, if you look at our portfolio, for a significant erosion. So that's first. Now, where the opportunity is coming is from launches.
You know, we just had our strategic day earlier this week, and I shared that in 2024, we had only five launches. So we are still suffering from historical gap from our decision to divest significant part of our portfolio in 2018. Again, it didn't come into fruition, but we didn't invest in the pipeline. So we did share again earlier in the week that we do have 70 products that are expected to launch in the US until 2028, and we believe that this portfolio is significant enough to, you know, to offset our erosion in the market. And, look, I want to put it out that we are not looking to be a leader in the generic space.
We want to be a sustainable player, and we'll continue to bring products where we believe we can sustain the supply to market. But we are not aiming to be a leader in this space.
That is clear. And moving out of the US and focusing on Europe, you launched biosimilar Stelara very recently in Europe. And right now, I think it's just you and Alvotech launching this product. So it's obviously very early, but if you could tell us a little bit about the reception, are you seeing any particular obstacles to launch or any early successes? Any color you can give us here?
No real obstacles. I mean, we have the full portfolio of strengths. So I think, again, that makes us relatively unique. And also, bear in mind, you know, we are the leading, one of the leading immunology companies in Europe anyway. So our ability with relationships with payers, prescribers, advocacy groups is very, very strong, and this has been an extremely well-received launch, and clearly, I guess, at our next sales update after Q3, we'll be able to give more details.
Yeah, very well. So maybe we do a little bit of a pause on the product questions and talk a little bit about the margins. I think margins that have come into debate at the second quarter earnings, you did 17.5% margin, EBITDA margin in the first half, and you need to achieve around 22.5% in the second half to kind of reach your margin guidance of around 10% for the year. So if you can remind us of the kind of different elements of this margin progression, and also an update on the cost-saving plan that is part of achieving this margin.
Remco?
Yeah, no, thank you for this for that question. Of course, it's a very steep improvement from the first half to the second half. But you have to consider, I think, a couple of elements in here, is one, as also Karen explained, the price erosion is relatively flat, going from the H1 to H2. As well, the cost erosion, which came in the system in the second half of last year, which was quite significant, was up to 10% of the total cost of goods sold. That has also come to a very, very low level, and actually, on the manufacturing side, we're actually seeing some benefit now coming in.
The big three drivers of the increase from 17.5 to the much higher number in the second half, they come from the whole mix, further mix improvement. You have seen that the biosimilars have been growing quite a bit, and that growth of over proportional growth of biosimilars in H2 versus H1 will continue, so you can do your own math because the margin is, of course, much better there. The second element is that absolute sales level in the second half year is quite a bit higher than it is in the first half, so there comes a natural leverage on the whole cost base. The last element is that the whole transformation program is now starting to bring the real cost savings in.
And for that, we expect about $50 million in the second half of this year, which is part of the top line, will be already around 100 basis points of the improvement. So those three are the three elements we are counting on for the second half year. But of course, it's to say it's a very steep increase, correct, for this part. We also often get a question, can we extrapolate that then into next year and the years after? And then you have to do the math, you very quickly get to 100%. Of course, that is not the right way of doing it. There were particular elements which in consideration.
But still, if for this year the 20% would be reached, and we still have the 24%-26% by 2028, we still count it, of course. Every single year we want to improve. But there are different elements which then the progression will influence. But don't extrapolate this 5% just like that.
That's clear. And on the cost-saving plans, can you just give a little bit more granularity on where are the pockets of saving you're making in terms of different functions, where you saw opportunities for cost savings?
No, I think what the company has done, splitting off of Novartis, is clearly looking what would be much more fit for purpose. So the layers in the organization have been reduced. In certain groups, also, the number of people have been reduced. It's basically everywhere other than direct sales force. So there we have said no, because in the sales force, we want to grow, we want to leverage, but there are no reductions there. But then it's in all the functions. It's in HR, it's in finance, it's also on the operational side. For this, we plan, which we also laid out, a restructuring cost of about CHF 350 million. CHF 140 million was taken in the first half of this year.
Depending on how negotiations go with the unions, we would have a similar amount in the second half of this year. It could be that a little bit goes into next year, and then the run rate of savings should come to around 200 million per year, but that's by 2026, because we still have to work then through 2025 to come in 2026 to that level. But it's across the board.
T hat, that's clear. So switching to one of the key topics of your strategic update, and you mentioned obviously the GLP-1 opportunity, where people are getting excited. So if you could talk a little bit about how you I mean, you framed it at your strategic update, but if you can give us a view on how you're thinking about addressing this market. You know, obviously the demand is massive, and there are some, I would say, constraints in terms of the capacity, you know, supply challenges. So if you could kind of give us an overview how you're thinking about the GLP-1 opportunity.
I will do. You know, we get a lot of questions, and I think partly everyone's trying to sort of square this disconnect between the amount of CapEx that the originators are spending versus the amount of CapEx that potentially we would need to spend and how we view the market. First of all, I'll just remind you, we're an injectable company, you know? But... Certainly our, if you look at our biologics business, so we're investing in capacity for injectables anyway, so that's just an important to have that at the back of your mind. The way I think about GLP-1 is really in three phases. You've got 2026 to 2030, which is really... Canada is the first market to, for sema, to be launched, around 2026. That's the second largest market in the world. But it will be interesting.
How that market will evolve, I have no idea. But certainly we have a partner. We've filed, and we're confident we would be at market formation when that market opens up. We're anticipating in 2026. In parallel to that then, you've got a number of emerging markets, Brazil, Turkey, et cetera, et cetera, all start coming off 2026 onwards, and the potential in those markets in terms of access is huge. As I think I commented the other day, you know, a market like Brazil, it's actually predominantly dentists who prescribe a lot of these class of drugs because it's in terms of those are the patients who are currently accessing it. So how that's gonna evolve. And so really sort of that, the first wave, we will use a mixture of in-house capacity and third-party capacity.
We're not manufacturing API. We have partners for the API. We're not constrained about, concerned about the capacity. I have no idea what the forecast would be. I could come with a very big number or a slightly more modest number, but it's gonna be super interesting. Then as you get into sort of the 2030s, is really when the regulated markets start falling. Now, you know, I can fully expect the originators will do everything in their power to make our life difficult. That's part of the game. So I can see, you know, the U.S. and Europe starting to come down for semaglutide 2032, 2033, that sort of timeframe. And then, you know, tirzepatide, Mounjaro, doesn't come off patent until I think 2035.
So this is a ten-year journey, at least, before you even then get into are we gonna migrate to the next generation? Are they gonna migrate to orals? You know, and in terms of our CapEx needs, it's gonna be in the hundreds of millions, not the billions, because ultimately we're investing in fill finish capacity and injector capacity, which predominantly we're gonna have to invest in anyway as we expand the biologics business. So I think, you know, super excited. It's not in our guidance in terms of our numbers. It's clearly an opportunity and one we would intend to be a serious participant. But that's really how I see it. Hopefully it answers most of your questions.
No, it does. It's helpful. So also a supply question, but this time more on the biologic side of the business, 'cause the feedback we get from, you know, talking to CDMOs is that there is currently some supply constraints on large-scale biologic capacity, which is, you know, to my understanding, the type of capacity you would need for biosimilars, and I'm talking about the industry in general. So with your biosimilar portfolio growing at a global level, multiple new launches planned, you will definitely need, you know, additional capacity-
I n coming years. So if you could just talk us through your strategy for supply, generally speaking, to supply your portfolio.
Yeah. I mean, today, predominantly, Novartis is still one of our main suppliers. That's on a long-term agreement, and it's on a cost-plus basis. It's not in terms of a CDMO relationship. So we have a very good cost of goods. In fact, we've just expanded the capacity around the initial MSA agreement to build more capacity. Now, Novartis clearly likes that, drives strong recoveries, and we're happy that they are supplying us. At the same time, we're investing in Slovenia, and that plant should be completed by 2026, and then probably 18 months, two years of tech transfer, so 2028. That will give us access to improved COGS and clearly additionally, a step change in terms of capacity. At the same time, we're working with a number of CDMOs.
And also, clearly, we could continue to use Novartis even when Slovenia's up and running, so that doesn't necessarily terminate that relationship. And on top of that, clearly, we have the potential partnership with Just Evotec Biologics to in-license or bring their J.POD technology, which could be a game changer in terms of both capacity and yield, and ultimately cost of goods. So I think we've got a multipronged strategy that gives us security of supply. I mean, the biggest problem that I have in this industry is really probably with the exception of natalizumab, we never supply 100% of any market. So if one of our competitors' sites gets blown up in a volcano somewhere, for argument's sake, how do I fill that capacity overnight?
It's very, very difficult because you're, you know, you're filling, you're planning capacity particularly 18 months, two years out. So building some flex, I think is also important.
That's clear, and in connection with all of this, you mentioned a bit about CapEx. You have your target, you know, of $2.3 billion CapEx plus, you know, hundreds of millions of dollars, potentially, depending on the GLP-1 opportunity, but even excluding GLP-1, is there some flexibility on these numbers if you start to see that, you know, growth is accelerating maybe beyond your plans or some biosimilars, you know, are taking off faster than others. Kind of how you're thinking about this initial target that you set and the flexibility around here?
I think in the plans which we have for the CapEx, correct, there's about two billion for the coming years in which for a significant part is related to the further growth, particularly in Slovenia, the on-site for biosimilars we set up. And progressively, over the years, we will further grow this, correct? And it's partly in the horizon, it's partly outside the horizon, but we believe that out of the free cash flow we have, we can all finance this, so.
That's clear. And still related to capital allocation, maybe if you could tell us a little bit about business development and M&A. You've done some small, I would say, in licensing deals around here, but how would you frame, first, your capital allocation priority, and second, how you're thinking about business development to supplement your growth?
Now, with the separation in October last year, correct, our first focus is really internal, correct? Getting the transformation done, getting the organization really spotless, correct, in terms of its operating model. I think that's clearly number one, and everyone is there. Clearly, on the biosimilar side, we have a disproportionate growth on this, and also ensuring that all our development on the longer term is in that direction and driving the mix also within generics, I would say, is the first one from a business perspective. Within that portfolio, there are opportunities, of course, for M&A, and we'll selectively look in M&A opportunities. At the moment, we will be looking at, say, 1% of inorganic growth a year on average, mostly through buying parts of new portfolio.
Anything bigger than that, that is not on the radar screen at this point in time.
That's very helpful. Coming back maybe on some product questions. Richard, you mentioned the success of Omnitrope, and, you know, your market shares keep going up, 38% of the last update. So, you know, how high can you go here? What's the outlook for this product, and then, yeah, how much room do you have to grow on this part of the market?
Look, I'll go beyond. I mean, some of that, clearly, a lot. Some of that success has been down to two of the originators deprioritizing supply to prioritize GLP-1s. I see no signal for them really coming back in material terms for the next, certainly for the foreseeable future. Then clearly, even in the U.S., one of the other players has now formally pulled out as well. I think it's leaving a space. Generally, once kids start this therapy, they generally stick with it until they've reached adulthood. Those patients are pretty sticky, so I would anticipate modest incremental growth going forward.
Understood. That's clear. And you mentioned as well, Natalizumab Tysabri, so you gave us an update on the launch in Europe and how encouraging it is. Maybe starting here, do you see any kind of obstacle, friction on the market in Europe? And I guess the problem with multiple sclerosis in particular, you have so much innovation in this space. I think even before you came in, this product was already starting to decline in volume. So could you reintroduce volume growth here? How are you thinking about your biosimilar in the context of innovation in this condition?
There's still a lot of patients who want access to this product, either governments or that it's not available to them in Europe anyway. I still think there's an opportunity as part of the portfolio of therapies for multiple sclerosis. The acceptance of this product has been very good. You know, in some of the Nordic markets, we've taken significant proportions of the share through national tenders. In individual markets where it tends to be more physician-led, we're well accepted, payers like us, patient advocacy groups support us. I think I don't see any concern. Ultimately, look, this is never about a big volume strategy. This is a relatively modest product. It's only $2 billion globally. But what's important is we're never likely to see a competitor.
So how we can then continue to work with payers in this space, it's a complicated product with the JCV assay and the REMS program. But certainly very pleased with where we are today.
That's clear. Thank you. Let's talk also a little bit about biosimilar Humira, and the timing here, so you had an approval in the U.S. last month for biosimilar Humira, Eylea, sorry. I get the-
Right. Too, too many biologics.
Can you just remind us what are the key challenges from an IP perspective and the timing to get a resolution on that for biosimilar Eylea in the U.S.?
Look, we're pleased we've got the approval. Beyond that, I'm not gonna comment other than say it'll be between now and, you know, end 2027. Clearly, we'll now go through the usual patent dance, of which I'm not gonna disclose anything, and so we'll see. I mean, clearly, I'm pleased we've got the approval. I look forward to bringing the product into Europe, I think late 2025, early 2026, that sort of timeframe. And clearly, we have biosimilars in the US to give us a platform and a bunch of specialist sales organizations used to dealing with physicians in this space. So we're well positioned when we launch to perform, but, we will see.
That's clear, and-
Did I get that right, Karen?
Perfect.
Obviously, you know, the brand originators are working very hard on trying to switch, you know, patients from the low dose two milligram of Eylea towards the high dose version, eight milligram. So, you know, how is that dynamic potentially impacting or slowing you down, and do you think you could convert high dose patients to low dose, or do you feel it's going to be complicated here?
I s this U.S. specific, probably?
No, Europe as well, I think.
I'm going to pass comment about Europe and then Karen, U.S. I mean, I think, look, this is still a large market, and again, you know, there's a cost point, so, you know, when we look at this, we still see this as a significant opportunity, and equally conversion from other products, well, not just necessarily the same drug class, so I think it is still very attractive, and I think from the U.S.
Yeah, I would say, first of all, similar. Also, of course, you know, it will be dependent on different factors like reimbursement, et cetera. But we do see a lot of products that have high dose or sub-Q options or long-acting, and we still see a very consistent share for the product. So we do believe that there is significant market. Definitely, some of the patients would move, but not all of them. And also, we need to remember here, you inject something to the eye, so we do believe that, you know, physician will look patient by patient and will decide, you know, clinically what they want to do, and then it will follow the reimbursement model.
Very clear. And still on Eylea, at least one biosimilar company has disclosed that they're working already on the high-dose formulation. And so is it something you're interested in? Do you think it's even worth it? What is your kind of thinking about developing potentially a high-dose version?
It's something we would disclose if and when we get to phase three trial.
Understood. Okay, and then maybe in the time we have left, last question on biosimilar interchangeability in the US. That's something that has been a debate before, and you have clearly proven with Humira that you don't need interchangeability status to be successful. That's been clear. But that being said, when Cigna did their private label deal, they clearly mentioned interchangeability as one of the key reasons why they chose their partners. So how are you thinking about this going forward? Is it something that you could work on for future biosimilars, or do you think it's still not that relevant in the US?
From my point, and then I'll let Karen comment, I think it's completely irrelevant. I mean, ultimately, we've got 80% share of the open 20%. Now, to be fair, one of our presentations is interchangeable, but the way the FDA has originally characterized interchangeability, to me, makes no sense whatsoever. It doesn't mean product A and B are interchangeable with C and D. It makes no sense. Now, clearly, Ranibizumab is interchangeable. We've got a designation there, so if we can get it through the filing process, why not? It does, and it does no harm. But honestly, I think now the...
I was with the head of the FDA, a couple of months ago, and clearly, they're moving much more to a European lens than, in a sense, once you're given an approval, it is interchangeable with the originator, which makes far more sense. So I just think, look, you know, and that's been sort of my perception. I don't know what your experience is.
Yeah, no, I fully agree on the FDA, first of all, and we definitely see that the kind of their paper and where they are going, and we agree with their position. I would say that interchangeability is one factor, like going with many others, that will be relevant, and it really depends on the stakeholders. But as Richard said, our ability to be successful and win even the Cordavis kind of, you know, process, we didn't have interchangeability back then. By the way, today we do have on our 10, 20, and 80 for the prefill syringe. But in reality, it didn't matter for the, you know, for the switch.
What really matters is the device that we have, the experience that we had outside the US, the patient service support that is, you know, very similar to what a branded company gives. So we do feel that there are many factors that make a difference, and interchangeability is one of them. But there is also something, you know. You think about interchangeability, it gives the ability to the pharmacy, right, to change the products without talking to the physician. When you talk about a patient, which is chronic patient, they usually want to hear the advice of their physician. So picking up the phone, get them on board, and then communicate it to the patient, we actually found it pretty useful.
That's very, very helpful. We're coming up to the end of the time, so thank you very much for taking the time today and be with us. We appreciate it.
Thank you so much. Thank you for your question.
Thank you.